1. Technical Field
The present invention generally relates to devices and methods for the reduction of the pain associated with needle sticks, including venipuncture and injection as well as the application of other sharps to the body. The present invention more specifically relates to a device using vibration or a combination of vibration and cold that is applied to a patient prior to and/or during the application of a needle or other sharp to the patient for the reduction of the pain associated with the application of the needle, methods for using the device, and methods for using vibration or a combination of vibration and cold for the reduction of the pain associated with the application of the needle.
2. Prior Art
According to many children, needle sticks are the most painful procedure performed in the hospital. The effects of untreated pain are remembered even by children too young to talk. Fear of needles and immunizations affect childrens' other healthcare experiences and parents' willingness to have them immunized. Needle phobia does not end in childhood. Geriatric patients cite it as a reason not to get a flu shot. Human immunodeficiency virus (HIV) patients say it is a reason for delaying being tested. The avoidance of obtaining dental care due to needle phobia is legendary.
Needle phobia is not isolated to the United States. In a survey asking for a blood sample for a study, 38% of adults in Singapore cited fear of needles and injections as their reason not to participate. Adolescents in Norway delayed or would not seek medical treatment due to fear of needle pain.
Effective means to decrease needle pain include local analgesia, distracting the patient, and confusing the nerves. Topical analgesics can reduce or eliminate needle pain, but cost between US $12 and US $150 per patient use. In addition, topical analgesics require prolonged application times or can cause vasoconstriction decreasing venipuncture success. Several devices either deliver lidocaine over 10 minutes using either electrical current (iontophoresis) or ultrasound, but the cost for these starts at US $50 per delivery.
The nerve fibers that transmit pain also transmit cold and vibration senses. Cold spray has been used at the site of a needle stick, but this actually increases distress in small children and causes vasoconstriction. Vibration has long been used to decrease the pain of dental injections, but vibrating needles have not been found to be effective in other dermal situations. Use of a simple hand-held vibrating massager has decreased injection pain in adults, but has been used alone without the adjuvant of cold therapy and has not been tested in children.
The related art devices generally are designed to be used at the site of the needle pain, rather than several centimeters proximal to the site. Further, none of the related devices incorporates the application of cold. Applying cold or vibration at the site, or immediately proximal to the site, can create logistical problems for the medical practitioner, and can cause a heightened anxiety in the patient, by requiring a plurality of devices to be located in a single location. Thus, such devices have a disadvantage.
Therefore, there is a need for an intentional agent (device and/or method) to decrease the pain of immunization, infiltration, injection and venipuncture, which would include both cold and vibration stimulation. Such a device should be reusable, easy to clean, tolerable to children and adults, and should incorporate a method to be adapted for use in the developing world (for example, operation with a power cord, with a battery, with a solar or light cell, or without the need for external power). As distraction also is an effective method for decreasing pain in children and adults, embodiments that include bright colors, ornamental designs, or simple tasks also are contemplated.
Accordingly, there is a need for a device method that allows for the reduction of the pain associated with hypodermic needle sticks. There also is a need for a device and method using vibration or a combination of vibration and cold that is applied to a patient prior to and/or during the application of a hypodermic needle to the patient for the reduction of the pain associated with the application of the hypodermic needle. It is to these needs and others that the present invention is directed.